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Multiple Comparisons of Treatments with Stable Multivariate Tests in a Two‐Stage Adaptive Design, Including a Test for Non‐Inferiority
Author(s) -
Kropf Siegfried,
Hommel Gerhard,
Schmidt Uwe,
Brickwedel Jens,
Jepsen Marilene Sophia
Publication year - 2000
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/1521-4036(200012)42:8<951::aid-bimj951>3.0.co;2-#
Subject(s) - multivariate statistics , statistics , stage (stratigraphy) , mathematics , multivariate analysis , test (biology) , computerized adaptive testing , adaptive design , medicine , biology , psychometrics , clinical trial , paleontology
The application of stabilized multivariate tests is demonstrated in the analysis of a two‐stage adaptive clinical trial with three treatment arms. Due to the clinical problem, the multiple comparisons include tests of superiority as well as a test for non‐inferiority, where non‐inferiority is (because of missing absolute tolerance limits) expressed as linear contrast of the three treatments. Special emphasis is paid to the combination of the three sources of multiplicity – multiple endpoints, multiple treatments, and two stages of the adaptive design. Particularly, the adaptation after the first stage comprises a change of the a‐priori order of hypotheses.